FDA Issues Warning to Innovative Neutronics

The FDA recently issued medical device maker Innovative Neutronics a warning letter after the firm did not ensure its contract manufacturer met quality requirements, which were found to be lacking during August and September inspections by the agency, after numerous complaints and two product recalls.
In a letter dated Nov. 4 , the Austin, TX-based company was cited for not documenting design changes for actions taken in response to complaints about defective devices and given 15 working days to come up with steps to fix the violations.
“On October 3, 2008, we received a response from your firm, dated September 19, 2008, to our investigator’s inspectional observations. The Agency acknowledged your commitments to improve your firm’s compliance with the quality system regulation. However, your firm’s response does not completely resolve several inspectional observations … ,” a letter from the FDA said.
The FDA said Innovative Neutronics still needs to create a plan to improve the quality of devices from its contract manufacturer and verify their effectiveness. The agency said follow-up inspections need then to be scheduled. It warned that if progress is not made, regulatory action is a possibility.
Innovative Neutronics did not respond to repeated phone calls seeking comment.